Guidance: Section 232 Duties on Imports of Patented Pharmaceutical Articles and Ingredients
CBP issues guidance for implementation of Section 232 duties on patented pharmaceutical products and active ingredients under Presidential Proclamation 11020. Duties become effective July 31, 2026 for companies listed in Annex III (up to 100% ad valorem) and September 29, 2026 for all other companies. Generic pharmaceuticals are exempt.
What changes
Section 232 duties are implemented on patented pharmaceutical products and ingredients (APIs and key starting materials) classified under HTSUS Chapters 29 and 30. Effective July 31, 2026, all importers must report Chapter 99 classifications (9903.04.60-9903.04.69). Rates vary by origin and status: 100% for Annex III companies, 15% for products from Japan, EU, South Korea, Switzerland or Liechtenstein, 10% for UK, 20% for qualifying onshoring plans, and 0% for generics, US-origin API products, and companies with MFN pricing agreements.
Who is impacted
Importers, customs brokers, and filers of patented pharmaceutical products and active pharmaceutical ingredients. Pharmaceutical companies importing APIs and key starting materials. Patented drug manufacturers from all countries, especially those listed in Annex III of Proclamation 11020. Does not affect importers of generic pharmaceuticals.
Recommended actions
- ›Verify if your pharmaceutical products are classified under HTSUS Chapters 29 or 30 subject to this measure
- ›Determine if the manufacturer is listed in Annex III of Proclamation 11020 to know the applicable effective date
- ›Starting July 31, 2026, report the corresponding Chapter 99 classification (9903.04.60-9903.04.69) on all entries
- ›For companies not listed in Annex III, use HTSUS 9903.04.61 (0% duty) until September 28, 2026
- ›Verify eligibility for reduced rates by origin (Japan, EU, Switzerland, Liechtenstein, UK)
- ›Evaluate options for onshoring plans or MFN pricing agreements with the Commerce Department
- ›Consider drawback available for duties imposed under this proclamation
On July 30, 2026, CBP issued guidance CSMS #69395344 to implement Section 232 duties on patented pharmaceutical products and ingredients under Presidential Proclamation 11020 of April 2, 2026. This measure establishes additional duties on imports of patented medications, active pharmaceutical ingredients (APIs), and key starting materials classified under HTSUS Chapters 29 and 30. Generic pharmaceuticals and their associated ingredients are expressly exempt from these additional duties.
The duties become effective in two phases: July 31, 2026 for products of companies listed in Annex III of the Proclamation, and September 29, 2026 for all other companies. Regardless of company, effective July 31, 2026, all importers of goods classified under the subject Chapter 29 and 30 classifications must report an applicable Chapter 99 classification (9903.04.60-9903.04.69).
Duty rates vary significantly by origin and company status: 100% ad valorem for the general rate (9903.04.60), 15% for products from Japan, EU member countries, South Korea, Switzerland or Liechtenstein (9903.04.62), 10% for UK products (9903.04.63), and 20% for companies with qualifying onshoring plans which increases to 100% on April 2, 2030 (9903.04.64). Classification 9903.04.65 offers 0% for companies with onshoring agreements and MFN pricing, though it expires January 20, 2029.
Important exemptions are established: US-origin pharmaceutical products are not subject to these tariffs, generics (9903.04.67) have a 0% rate, and products with US-origin API packaged in dosage form (9903.04.68) are also exempt. Drawback is available for duties imposed under this proclamation. For goods eligible for special tariff treatment under free trade agreements or preference programs, these Section 232 duties are collected in addition to any applicable special rate of duty.